OnTrak 016-0109-04Q
GUDID 10841522102547
CUFF,ABP,XLGADLT,38-50CM/15-20IN,NO LTX,QKD/LEUR
SPACELABS HEALTHCARE (WASHINGTON), INC
Blood pressure cuff, reusable| Primary Device ID | 10841522102547 |
| NIH Device Record Key | ac26054b-1bb5-48e8-a966-1e9ddb131169 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OnTrak |
| Version Model Number | 90227 |
| Catalog Number | 016-0109-04Q |
| Company DUNS | 145581588 |
| Company Name | SPACELABS HEALTHCARE (WASHINGTON), INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 75 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841522102547 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141113
FDA Product Code
| DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-04-03 |
| Device Publish Date | 2016-11-21 |
On-Brand Devices [OnTrak]
| 10841522102547 | CUFF,ABP,XLGADLT,38-50CM/15-20IN,NO LTX,QKD/LEUR |
| 10841522102530 | CUFF,ABP,LG ADLT,32-42CM/13-17IN,NO LTX,QKD/LUER |
| 10841522102257 | CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX,QK DISC/LUER |
| 10841522102240 | CUFF,ABP,ADLT,24-32CM/9-13IN,NO LTX,QK DISC/LUER |
| 10841522102233 | CUFF,ABP,SM ADLT,17-26CM/7-10IN,NO LTX,QKD/LUER |
| 10841522129261 | CUFF,ABP,ADULT,XL,38-50CM/15-20IN,NO LTX |
| 10841522129247 | CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX |
Trademark Results [OnTrak]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ONTRAK 98077435 not registered Live/Pending |
U. E. SYSTEMS INCORPORATED 2023-07-10 |
 ONTRAK 97900460 not registered Live/Pending |
Rice Lake Weighing Systems, Inc. 2023-04-21 |
 ONTRAK 90100701 not registered Live/Pending |
Ontrak, Inc. 2020-08-07 |
 ONTRAK 88861815 not registered Live/Pending |
Catasys, Inc. 2020-04-06 |
 ONTRAK 88861808 not registered Live/Pending |
Catasys, Inc. 2020-04-06 |
 ONTRAK 88150071 5762290 Live/Registered |
Spacelabs Holdings, Inc. 2018-10-10 |
 ONTRAK 86406048 4708383 Live/Registered |
Baker Hughes Incorporated 2014-09-25 |
 ONTRAK 78269184 3330405 Dead/Cancelled |
Rice Lake Weighing Systems, Inc. 2003-07-01 |
 ONTRAK 78138887 2830788 Dead/Cancelled |
D.C.D. Global, Inc. 2002-06-26 |
 ONTRAK 78082951 2815707 Dead/Cancelled |
Baker Hughes Incorporated 2001-09-06 |
 ONTRAK 78082946 not registered Dead/Abandoned |
Baker Hughes Incorporated 2001-09-06 |
 ONTRAK 78002872 not registered Dead/Abandoned |
Lat-Lon, L.L.C. 2000-04-06 |
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